Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
Ann Oncol. 2013 May;24(5):1326-31. doi: 10.1093/annonc/mds629. Epub 2012 Dec 30.
A phase III study (Lung Cancer Evaluation of TS-1) previously demonstrated noninferiority in terms of overall survival (OS) at interim analysis for carboplatin-S-1 compared with carboplatin-paclitaxel for first-line treatment of advanced non-small-cell lung cancer (NSCLC).
A total of 564 patients were randomly assigned to receive either carboplatin on day 1 plus oral S-1 on days 1-14 or carboplatin-paclitaxel on day 1 every 21 days. Updated results and post hoc subgroup analysis according to tumor histology are presented.
The updated analysis revealed a median OS of 15.2 months in the carboplatin-S-1 arm and 13.1 months in the carboplatin-paclitaxel arm, with a hazard ratio (HR) of 0.956 [95% confidence interval (CI) 0.793-1.151], consistent with the previous primary analysis. Median OS was 14.0 months in the carboplatin-S-1 arm and 10.6 months in the carboplatin-paclitaxel arm (HR 0.713; 95% CI 0.476-1.068) for patients with squamous cell carcinoma (SCC), with corresponding values of 15.5 and 13.9 months (HR 1.060; 95% CI 0.859-1.308) for those with non-SCC.
These results establish the efficacy and safety of carboplatin-S-1 in patients with advanced NSCLC regardless of tumor histology.
一项 III 期研究（肺癌 TS-1 评价）在中期分析时证明，卡铂-替吉奥（S-1）方案在总生存期（OS）方面非劣效于卡铂-紫杉醇方案，适用于晚期非小细胞肺癌（NSCLC）的一线治疗。
共有 564 例患者被随机分配接受卡铂加 S-1 或卡铂加紫杉醇治疗。结果和根据肿瘤组织学的事后亚组分析进行了更新。
更新的分析显示，卡铂-S-1 组的中位 OS 为 15.2 个月，卡铂-紫杉醇组为 13.1 个月，风险比（HR）为 0.956（95%置信区间[CI]0.793-1.151），与之前的主要分析结果一致。鳞癌患者中，卡铂-S-1 组的中位 OS 为 14.0 个月，卡铂-紫杉醇组为 10.6 个月（HR 0.713；95% CI 0.476-1.068），而非鳞癌患者中，相应的中位 OS 为 15.5 个月和 13.9 个月（HR 1.060；95% CI 0.859-1.308）。
这些结果确立了卡铂-S-1 在晚期 NSCLC 患者中的疗效和安全性，无论肿瘤组织学如何。
